Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

ValueSet: Limited M11 Section Codes Value Set

Official URL: http://hl7.org/fhir/uv/ebm/ValueSet/limited-m11-section-codes Version: 1.0.0-ballot3
Standards status: Trial-use Maturity Level: 1 Computable Name: LimitedM11SectionCodes
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.48.24

Copyright/Legal: Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license.

These codes are specified in the M11 technical specification.

References

Logical Definition (CLD)

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version Not Stated (use latest from terminology server)
    CodeDisplay
    C217342ICH M11 Protocol Section 1 PROTOCOL SUMMARY
    C217343ICH M11 Protocol Section 2 INTRODUCTION
    C217344ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS
    C217345ICH M11 Protocol Section 4 TRIAL DESIGN
    C217346ICH M11 Protocol Section 5 TRIAL POPULATION
    C217347ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
    C217348ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL
    C217349ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
    C217350ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
    C217351ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
    C217352ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
    C217353ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS
    C217354ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS
    C217355ICH M11 Protocol Section 14 APPENDIX: REFERENCES
    C217356ICH M11 Protocol Section Title Page
    C217357ICH M11 Protocol Section Amendment Details

 

Expansion

This value set expansion contains 16 concepts.

SystemCodeDisplayJSONXML
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217342ICH M11 Protocol Section 1 PROTOCOL SUMMARY
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217343ICH M11 Protocol Section 2 INTRODUCTION
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217344ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217345ICH M11 Protocol Section 4 TRIAL DESIGN
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217346ICH M11 Protocol Section 5 TRIAL POPULATION
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217347ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217348ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217349ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217350ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217351ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217352ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217353ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217354ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217355ICH M11 Protocol Section 14 APPENDIX: REFERENCES
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217356ICH M11 Protocol Section Title Page
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217357ICH M11 Protocol Section Amendment Details

Description of the above table(s).